Roche’s Alecensa demonstrates a remarkable 76% reduction in the risk of disease recurrence or death in early-stage anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC), as per the primary analysis of the Phase III ALINA study. This groundbreaking achievement highlights the potential of Alecensa to redefine the management of early-stage ALK-positive lung cancer, which currently lacks effective treatment options. Disease recurrence affects nearly half of early-stage NSCLC patients, emphasizing the need for improved therapeutic approaches. Alecensa’s efficacy data in this trial are expected to pave the way for a new standard of care in the ALK-positive early lung cancer domain, offering new hope to patients where options are currently limited.
The study reveals that Alecensa significantly enhances disease-free survival (DFS) by an unprecedented 76%, marking a major shift in early-stage ALK-positive NSCLC treatment. The data also demonstrate a significant improvement in the central nervous system (CNS) DFS. The safety profile of Alecensa aligns with previous trials in the metastatic setting, with no unexpected safety concerns. Overall survival data are still maturing, with ongoing follow-up.
This data could significantly benefit patients with ALK-positive NSCLC, a group at higher risk of brain metastases and generally younger than those with other NSCLC types. Disease progression, once it occurs, is typically incurable. The findings indicate the potential for Alecensa to alter the course of the disease, offering the best chance for a cure. With these promising results, Roche aims to collaborate with health authorities to expedite the availability of Alecensa to patients in this setting. The data were presented at the European Society of Medical Oncology (ESMO) Congress 2023 Presidential Symposium and will be submitted to global health authorities, including the U.S. Food and Drug Administration and the European Medicines Agency. This achievement is a critical step in improving outcomes for patients with early-stage ALK-positive NSCLC and demonstrates Roche’s commitment to addressing unmet medical needs.
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